Roderick M. Cameron, Ph.D.
In the vaccine field, the most common approach to evaluating the immunological performance of a vaccine is to assess the serological response generated by subjects enrolled in a clinical trial. Usually, this occurs by testing serum or plasma, although other matrices may also be tested (e.g., urine, saliva, stools, etc.).
David J. Snodin, Ph.D., David P. Elder, Ph.D.
This second article on genotoxic / mutagenic impurities (GTIs) will focus on toxicological aspects and discuss in more detail some of the themes mentioned in the first part of the series [1]. The current [2,3] and evolving guidance [4] is based on a number of key toxicological principles:
Scott M. Wheelwright, Ph.D., Peter Soelkner, MBA, Michael Jenkins, Kent Payne, Ph.D., Curtis Gingles, Larry Thomas
One area where we see continued change in the industry is in the use of single-use (disposable) materials for processing. These materials include bioreactors, solution storage containers, filters and other items that are used for one or a few batches of production and then are replaced with new materials.
Melissa Germain, M.Sc., Jean-Pierre Emond, Ph.D.
Mail order pharmaceutical sales are the largest growing segment in the drug retail industry, with over 240 million prescriptions per year [1]. In 2010, approximately $182 billion dollars worth of pharmaceuticals required the maintenance of a specific temperature in order to preserve their potency and effectiveness [2].
Eric S. Langer
China continues its remarkable advance last year as the most likely outsourcing destination, edging out stalwarts U.S. and Germany. In our 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, research analysis from 302 biopharmaceutical manufacturers in 29 countries indicate that China is, by far, expected to be the most popular country, of the 25 countries identified as outsourcing partners, over the next five years [1].
Lorna Brazell
One of the biggest challenges in the biotech industry is how to secure sufficient funding to support product or technology development. Partnering with companies that have capital, as well as technical and regulatory expertise – which, for the most part are larger biotech or pharmaceutical industries – may for many small biotech companies be more appealing than dealing directly with the financial markets.
Paul Doherty, MS
The single largest trend impacting all APIs, high potent or not, is the return of business from Asia and other newly developed regions to the traditional pharmaceutical manufacturing regions of the world due to increased concerns about quality and a growing appreciation of the importance of the quality systems and culture that have been established in Japan, North America and Western Europe.